USPTO Patents Application 10042998

Serial No.: 10/042,998
Art Unit: 3731

REMARKS

This responds to the Office Action dated April 8, 2004.

A restriction was required, requiring the election of one of four inventions as set forth by
the Examiner. Group 2, containing claims 26-35 was elected.

The other claims of the application, claims 1-25 and 36-54 are being cancelled herewith.
Additional claims 55-74 are being added.

A feature of the invention is the anoscope that can be used in combination with a ligator
device and the loading device as described in the application. The anoscope is disclosed in detail
beginning at the last paragraph of page 9 of the specification and continuing on to page 12. A
feature of the anoscope is the openings that extend from the distal end back toward the proximal
end of the conical shaped scope. The openings extend approximately halfway along the length of
the anoscope. That leaves the solid portion of the scope in the vicinity of the external
hemorrhoids, with the openings placed adjacent the classical positions of the internal
hemorrhoids. This blocks the external hemorrhoids from protruding in the way of the surgeon: as
the internal hemorrhoids are ligated. The anoscope can be used with other types of ligators
and/or rubber band loading devices.

Claim Objections

Claim 32 was objected to as having numerals that were not enclosed within parentheses.
This has been corrected by elimination of the numerals.

Specification

The specification was objected to because Fig. 5 is not discussed in the specification.
Fig. 5 has been renumbered as Fig. 6. Fig. 6 is described in the specification.

Drawings

The drawings were objected to because they must show every feature of the invention
specified in the claims. The springs of the ratchet device must be shown or this feature cancelled

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Art Unit: 3731

from the claims. Applicant is submitting a proposed modification to Fig. 7 of the drawings that
shows the springs.

Claim Rejections -35 U.S.C, S 112

Claim 34 was rejected under § 112, first paragraph, because it contained subject matter
which was not described in the specification in such a way as to enable one skilled in the art to
make and/or use the invention. Applicant proposes to modify Fig. 7 of the drawings to conform
it to the description in the specification and in claim 34.

- Claim Rejections - 35 U.S.C. § 103

Claims 26-32 and 35 were rejected under § 103(a) as being unpatentable over Watson, et
aL 5,788,715 in view of Bidom 5,203,863, and further in view of Longo^etaL 6,142,933.

The Watson, et aL , Bidoia, and Longo, et aL patents do not disclose the features of the
invention, including an anoscope that is used in combination with the rubber band ligator and the
loading device, whereby the anoscope has a hollow cylinder with multiple apertures formed
about the hollow cylinder at positions about the cylinder for simultaneously exposing
hemorrhoids in the anal canal, as generally described in claim 26. More particularly, none of the
references disclose the concept of the openings being three openings at the normal anatomic
locations of the hemorrhoids in a patient, as generally described in claim 27. Further, the applied
prior art does not show the concept of permitting simultaneous access to the normal locations of
internal hemorrhoids. Further, the prior are does not teach the concept of having the openings in
the anoscope extend about half way from the distal end so that the solid proximal end of the
anoscope is used to block the protrusion of the external hemorrhoids from interfering with the
movements of the surgeon during the ligation procedures on the internal hemorrhoids, as
generally described in claim 27.

Internal hemorrhoids are classically oriented in predetermined locations, much like the
nose and ears of the human head. The placement of the openings of the anoscope in positions
that correspond to the normal hemorrhoid locations is a substantial advantage over the prior art,
in that it provides the surgeon with access to the internal hemorrhoids with only one insertion of

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the anoscope, avoiding the retraction and reinsertion of the anoscope to expose the hemorrhoids
in sequence.

Claims 28-35 set forth the several advantages of the ligator device.

The new claims, claims 55-75 emphasize some of the improved features of the anoscope.
The applied references do not disclose the anoscope having the three lateral apertures extending
along the cylinder from the distal end toward the proximal end, with the apertures being spaced
apart about the cylinder to be positionable at the 3 o'clock, 7 o'clock and 1 1 o'clock positions
about the cylinder when the cylinder is inserted in the anal canal with the patient in the supine
position.

Another feature that is not disclosed in the prior art is the combined width of the three
lateral apertures being approximately equal to one half of the circumference of the cylinder and
the cylinder being tapered at its distal end, with the openings extending approximately halfway
along the length of the cylinder, so as to expose the internal hemorrhoids while avoiding
obstruction by the external hemorrhoids.

Further, the prior art does not appear to disclose the handle extended from the external ,
flange that extends radially from the proximal end of the cylinder, the flange, the handle
incorporating a housing for attachment of an external light source and a fiber optic cable, with
the handle being oriented on the flange to be in the 12 o'clock position when the openings in the
cylinder are oriented properly in the anal canal at the 3 o'clock, 7 o'clock and 1 1 o'clock
positions, and the openings in the cylinder each extending about the cylinder approximately 1/6
of the cylindrical circumference.

Another feature not disclosed by the prior art is a handle of an anoscope oriented with
respect to the openings of the anoscope so that when the anoscope is inserted in the anal canal the
surgeon know where the openings are located by the position of the handle and the hemorrhoids
are received in the openings.

Claims 55-77 are directed to the combination of the anocope and the ligator and its
loading cone, the anoscope having the various features of the arrangement of the apertures so that
they receive the hemorrhoids, and some claims including a handle extending radially away from
the proximal end of the cylinder at a predetermined angle with respect to the apertures of the
cylinder such that when the cylinder is inserted in the anal canal of the patient and the handle is

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oriented at a predetermined attitude with respect to the patient and the apertures of the cylinder
register with the internal hemorrhoids of the patient. For example, see claim 76. Again, the
applied references do not anticipate or make obvious these features.

The references of record in the application have been reviewed, and applicant submits
that the subject matter of the claims is not disclosed in or made obvious by these references,
taken individually or in combination. Accordingly, applicant submits that the claims of the
application should now be in condition for allowance, and appropriate action is requested.

THOMAS, KAYDEN,
HORSTEMEYER & RISLEY, L.L.P.

Suite 1750

100 Galleria Parkway N.W.
Atlanta, Georgia 30339
(770) 933-9500

Respectfully submitted,

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